Human Subjects Research

The Carnegie Mellon University Institutional Review Board (IRB)

All research involving the use of human research subjects (participants) must be reviewed and approved by the CMU Institutional Review Board (IRB) before the research can be initiated.

Research means a systematic investigation including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge; (see 45 CFR 46.102(l)).

Human subject means a living individual about whom an investigator (whether professional or student) conducting research: (i) Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or (ii) Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens. (45 CFR 46.102.e.1)

The primary responsibility of the IRB is to assure that appropriate steps are taken to protect the rights and welfare of humans participating in research. The IRB functions according to the guidelines of the Office of Human Research Protection (OHRP) and other federal regulatory agencies. The IRB is a committee with representation from CMU faculty and the community. The CMU IRB meets on the first Tuesday of every month. Protocols that are eligible for Exempt and Expedited Review are processed on an ongoing basis.

Important Dates for Protocol Submissions

The new Common Rule, which governs human subjects research (HSR), is effective for all new IRB protocols approved on or after January 20, 2019. To accommodate the transition to the new regulations, the following is planned for protocol submission via SPARCS:

Beginning on January 3, 2019 new IRB protocols may be submitted via SPARCS. Any new protocols submitted on or after this date will be subject to the new HSR regulations.

Protocols approved prior to January 20, 2019 will continue to be governed by the “pre-2018” HSR regulations for an undetermined period of time.

The IRB office will be especially busy during December and January so we’d really appreciate it if protocols are submitted well in advance of the anticipated start date.

*if a funding agency requires that a study is submitted and approved during this time period, the IRB will work with the researcher outside of the system.